Drug factory · FDA FEI 3003073605
Orion Corporation, Orion Pharma
Orionintie 1, Espoo, Finland
Problems found, fixed voluntarily at FDA's last inspection, Nov 7, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 1 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbidopa and Entacapone and Levodopa | Makes it, tests it, packages it and labels it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-001, 47335-002, 47335-003 +3 |
| Darolutamide | Makes it and tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-395 |
| Entacapone | Makes it, packages it and labels it | Caraco Pharmaceutical Laboratories, Ltd., Wockhardt Limited, Wockhardt USA LLC. | 47335-007, 55648-290, 55648-781 +1 |
| Methotrexate | Makes it, tests it, packages it and labels it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-235 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 7, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 1, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Apr 21, 2017 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Sep 5, 2014 | No problems found | Drug Quality Assurance | 3 |
| Dec 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 14, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 1, 2018 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - In-Process and Laboratory Control Results 21 CFR 211.188(b)(5)
The batch production and control records are deficient in that they do not include in-process control results. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Aseptic Processing Area 21 CFR 211.42(c)(10)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.
Sep 5, 2014 inspection
- Clothing appropriate for duties performed 21 CFR 211.28(a)
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
Certificates of testing of closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.
Registered with FDA for: analysis; label; manufacture; pack.